(85 days)
1844 & 1844-P: For use at the equipment connection. Designed to reduce bacterial/viral transmission to and from patient, equipment and environment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient; 1841 & 1841-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of pattent heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions; Do not use this product in conjunction with other humidification sources. 1844, 1844-P, 1841, 1841-T: ISO connections: When assembling any comnections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier; Do not use this product between the patient and a source of nebulized drugs; When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure; Pederal law restricts this device to sale by or on the order of a physician.
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The provided text is a 510(k) premarket notification approval letter for several medical devices (Clear-Therm HMEF, Clear-Therm HME W/Flextube, Clear-Guard II Filter, and Clear-Guard II Filter w/CO2 Monitoring Port).
This document does not contain information regarding detailed acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for AI-based medical devices.
The letter states that the devices are "substantially equivalent" to legally marketed predicate devices, meaning they have similar indications for use, technological characteristics, and safety and effectiveness. This determination is based on a comparison to existing devices rather than a de novo study with specific performance metrics against a defined standard.
Therefore, I cannot provide the requested information from the given text. The information requested typically comes from a separate summary of safety and effectiveness or a clinical study report, which is not part of this 510(k) approval letter.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).